Abstract
Intervention for individuals with autism spectrum disorder (ASD) typically commences after diagnosis. No trial of an intervention administered to infants before diagnosis has shown an effect on diagnostic outcomes to date. To determine the efficacy of a preemptive intervention for ASD beginning during the prodromal period. This 2-site, single rater-blinded randomized clinical trial of a preemptive intervention vs usual care was conducted at 2 Australian research centers (Perth, Melbourne). Community sampling was used to recruit 104 infants aged 9 to 14 months showing early behaviors associated with later ASD, as measured by the Social Attention and Communication Surveillance-Revised. Recruitment occurred from June 9, 2016, to March 30, 2018. Final follow-up data were collected on April 15, 2020. Infants were randomized on a 1:1 ratio to receive either a preemptive intervention plus usual care or usual care only over a 5-month period. The preemptive intervention group received a 10-session social communication intervention, iBASIS-Video Interaction to Promote Positive Parenting (iBASIS-VIPP). Usual care comprised services delivered by community clinicians. Infants were assessed at baseline (approximate age, 12 months), treatment end point (approximate age, 18 months), age 2 years, and age 3 years. Primary outcome was the combined blinded measure of ASD behavior severity (the Autism Observation Scale for Infants and the Autism Diagnostic Observation Schedule, second edition) across the 4 assessment points. Secondary outcomes were an independent blinded clinical ASD diagnosis at age 3 years and measures of child development. Analyses were preregistered and comprised 1-tailed tests with an α level of .05. Of 171 infants assessed for eligibility, 104 were randomized; 50 infants (mean [SD] chronological age, 12.40 [1.93] months; 38 boys [76.0%]) received the iBASIS-VIPP preemptive intervention plus usual care (1 infant was excluded after randomization), and 53 infants (mean [SD] age, 12.38 [2.02] months; 32 boys [60.4%]) received usual care only. A total of 89 participants (45 in the iBASIS-VIPP group and 44 in the usual care group) were reassessed at age 3 years. The iBASIS-VIPP intervention led to a reduction in ASD symptom severity (area between curves, -5.53; 95% CI, -∞ to -0.28; P = .04). Reduced odds of ASD classification at age 3 years was found in the iBASIS-VIPP group (3 of 45 participants [6.7%]) vs the usual care group (9 of 44 participants [20.5%]; odds ratio, 0.18; 95% CI, 0-0.68; P = .02). Number needed to treat to reduce ASD classification was 7.2 participants. Improvements in caregiver responsiveness and language outcomes were also observed in the iBASIS-VIPP group. Receipt of a preemptive intervention for ASD from age 9 months among a sample of infants showing early signs of ASD led to reduced ASD symptom severity across early childhood and reduced the odds of an ASD diagnosis at age 3 years. http://anzctr.org.au identifier: ACTRN12616000819426.
Highlights
A randomized clinical trial of 54 infants with an increased familial likelihood of Autism spectrum disorder (ASD) found that receipt of the iBASISVIPP intervention from age 9 months led to a significant reduction in the severity of emerging ASD symptoms over the prodromal period when measured up to age 3 years.[23,24]
Meaning This study found that a preemptive intervention reduced ASD diagnostic behaviors when used at the time atypical development first emerges during infancy
Following a prespecified protocol, the clinicians assessed participant status on each of the 7 diagnostic criteria specified for ASD in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5)[1]; these criteria were A1, A2, A3, B1, B2, B3, and B4
Summary
Previous randomized clinical trials of preemptive interventions have not demonstrated intervention effects on ASD symptom emergence.[7,8,9,10,11,12,13] recent advances in developmental science have provided key insights into potential intervention mechanisms,[14,15,16] regarding the ways in which adapted caregiver interaction styles can modify the effect of existing infant vulnerabilities in social attention[17,18] on later development.[19,20,21] The iBASIS–Video Interaction to Promote Positive Parenting (iBASIS-VIPP) intervention targets these developmental processes using video feedback techniques to increase caregiver awareness of their infant’s individual social communication and guide specific caregiver responses to build infant social engagement and interaction. A randomized clinical trial of 54 infants with an increased familial likelihood of ASD (based on having a sibling with ASD) found that receipt of the iBASISVIPP intervention from age 9 months led to a significant reduction in the severity of emerging ASD symptoms over the prodromal period when measured up to age 3 years.[23,24] this initial randomized clinical trial was underpowered to measure treatment effects on categorical ASD diagnosis, so the clinical significance of this finding remains uncert
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